Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar
27 other identifiers
observational
2,840
17 countries
17
Brief Summary
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2006
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 30, 2010
September 1, 2010
4.1 years
May 6, 2009
September 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor status
After about 3, 6, 9 and 12 months
Secondary Outcomes (5)
Treatment duration
At end of study after about 12 months
Safety of sorafenib treatment
At every documented visit for about 12 months
Progression-free survival
Calculation at end of study after about 12 months
Status of Metastases
After about 3, 6, 9 and 12 months
Performance status (ECOG)
After about 3, 6, 9 and 12 months
Study Arms (1)
Group 1
Interventions
Eligibility Criteria
Patients with a diagnosis of advanced RCC
You may qualify if:
- Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (18)
Unknown Facility
Many Locations, Argentina
Unknown Facility
Many Locations, Austria
Unknown Facility
Many Locations, China
Unknown Facility
Many Locations, Colombia
Unknown Facility
Many Locations, Czechia
Unknown Facility
Many Locations, France
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Greece
Unknown Facility
Many Locations, Indonesia
Unknown Facility
Many Locations, Mexico
Unknown Facility
Many Locations, Netherlands
Unknown Facility
Many Locations, Philippines
Unknown Facility
Many Locations, Poland
Unknown Facility
Many Locations, Russia
Unknown Facility
Many Locations, Slovakia
Unknown Facility
Many Locations, Slovenia
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
July 1, 2006
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 30, 2010
Record last verified: 2010-09